SubtleHD (1.x)
Subtle Medical, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Menlo Park
- Advisory committee description
- Radiology
- Address 1
- 883 Santa Cruz Ave.
- Address 2
- Suite 205
- Statement or summary
- Summary
- Product code
- QIH
- Zip code
- 94025
- Applicant
- Subtle Medical, Inc.
- Decision date
- 2025-02-12
- Decision code
- SESE
- Country code
- US
- Device name
- SubtleHD (1.x)
- Advisory committee
- RA
- Contact
- Ronny Elor
- K number
- K243250
- State
- CA
- Date received
- 2024-10-15
- Review advisory committee
- RA
- Postal code
- 94025
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Automated Radiological Image Processing Software
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- Registration number
- 3036502204, 3005403518, 1000432246, 9710090, 3018094310, 3028006458, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3010703925, 3008837339, 3003768277, 3018064242, 3044776706, 3015612252, 3010656400, 3019541896, 9680269, 3042248552, 3003899230, 3014310698, 3018302800, 1644408, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3016965352, 3002808157, 3004141078, 3016585383, 3020703662, 3006209933, 3019878658, 3008284470 +201 more
- FEI number
- 3036502204, 3005403518, 1000432246, 3018094310, 3028006458, 3003405980, 3003310366, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3003309342, 3008837339, 3010703925, 3018064242, 3044776706, 3015612252, 3003408255, 3019541896, 3010656400, 3003899230, 3042248552, 3014310698, 3018302800, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3003377038, 3016965352, 3002808157, 3016585383, 3004141078, 3002808529, 3002808382, 3020703662 +201 more